NCT04538404

Brief Summary

CR-POSSUM is one of the most used surgical scores to predict mortality after colorectal surgery. Its main drawback is the requirement of intraoperative variables, whose collection is time-consuming and prevents from obtaining a purely preoperative risk assessment. The primary aim of the study is to develop a new surgical score using preoperative parameters to predict 30-day mortality after colon cancer surgery in the elderly population. The secondary objective is to analyze its efficacy compared to CR-POSSUM.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
385

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2011

Longer than P75 for all trials

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2011

Completed
6.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 31, 2017

Completed
1.4 years until next milestone

Study Completion

Last participant's last visit for all outcomes

January 31, 2019

Completed
1.6 years until next milestone

First Submitted

Initial submission to the registry

August 22, 2020

Completed
13 days until next milestone

First Posted

Study publicly available on registry

September 4, 2020

Completed
Last Updated

September 4, 2020

Status Verified

August 1, 2020

Enrollment Period

6.7 years

First QC Date

August 22, 2020

Last Update Submit

September 3, 2020

Conditions

Keywords

colon cancersurgerymortalityelderlyscoring system

Outcome Measures

Primary Outcomes (1)

  • New surgical score using preoperative parameters to predict 30-day mortality after colon cancer surgery in the elderly population

    MEC Score (arterial saturation of O2, Systolic Blood Pressure, Heart Rate, WBCs, Albumin, Creatinine) for the evaluation of the risk of in-hospital mortality occurred during hospitalization up to 30 days

    Up to 30 days after surgery

Interventions

Colon SurgeryPROCEDURE

Right, left colon surgery, transverse colon surgery, multiple colon surgery in open and minimally invasive surgert

Eligibility Criteria

Age80 Years+
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Men and women patients aged 80 and above having elective and emergency colonic resection for colon cancer via open, laparoscopic and converted approaches.

You may qualify if:

  • Patients aged 80 and above having elective and emergency colonic resection for colon cancer via open, laparoscopic and converted approaches

You may not qualify if:

  • Surgical resections for rectal cancer and surgical procedures for non-neoplastic colon pathologies

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Bruno Nardo

Bologna, 40138, Italy

Location

Marialuisa Lugaresi

Bologna, 40138, Italy

Location

MeSH Terms

Conditions

Colonic Neoplasms

Condition Hierarchy (Ancestors)

Colorectal NeoplasmsIntestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesColonic DiseasesIntestinal Diseases

Study Officials

  • Bruno Nardo, MD,PhD

    University of Bologna

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Adjunct Professor MD, PhD

Study Record Dates

First Submitted

August 22, 2020

First Posted

September 4, 2020

Study Start

January 1, 2011

Primary Completion

August 31, 2017

Study Completion

January 31, 2019

Last Updated

September 4, 2020

Record last verified: 2020-08

Data Sharing

IPD Sharing
Will not share

Locations